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Posted April 8, 2003

FDA Acts Against Potentially Risky Products Illegally Marketed as Street Drug Alternatives

On March 31, the Food and Drug Administration (FDA) announced enforcement actions against firms that are marketing street drug alternative products, some of which contain ephedra or other sources of ephedrine. FDA sent warning letters to eight firms because they marketed products that they claim can be used as alternatives to street drugs.

Today's actions are the latest in a series of FDA moves designed to protect Americans from potentially serious risks of products claiming to be dietary supplements that may actually pose health risks.

The FDA is aware that some products purporting to be legal dietary supplements are being marketed as street drug alternatives. These street drug alternatives, however, are not dietary supplements under the legal definition, because they are not intended to be used to augment the diet, to promote health or to reduce the risk of disease. Therefore, these products cannot legally be marketed in the U.S. as dietary supplements.

FDA's actions today resulted primarily from the agency's active surveillance of these firms' web sites. The investigation revealed that these firms are selling their products for "recreational" purposes -- i.e., to affect the mental or psychological states of those taking the products. The products are marketed under a variety of names with labeling that claims or implies that they produce such effects as euphoria, a "high," altered consciousness, or hallucinations.

"Illegal street drugs masquerading as dietary supplements have no legitimate place in the U.S. marketplace," said FDA Commissioner, Mark B. McClellan, M.D., Ph.D. "These products pose potentially serious risks to minors and others who take them, without providing any medical benefits. Simply put, they pose an unacceptable risk to public health."

In March of 2000, FDA issued guidance for industry designed to prevent such marketing of street drug alternatives because of their potential public health risk. The guidance is available on line at www.fda.gov/cder/guidance/index.htm. FDA's action today warns firms to stop promoting their products as street drug alternatives and requests that the firms notify the agency within 15 days regarding the corrective action they plan to take.

Since the beginning of this year, FDA action against such street drug alternative products as "Black Beauties" and "Yellow Jackets" has resulted in the destruction of millions of dollars worth of these products.

For more information, including a link to the list of firms that have received warning letters, click on the Web address below.